Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596930
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2020-10-15
Brief Title:
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma a Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMITT
Brief Summary:
Objective In preparation of a randomized controlled trial the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy LITT at Radboud University Medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma as compared with standard of care
Study design Prospective randomized pilot study Randomization stopped amendment September 2nd 2021
Study population 20 patients aged 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection
Intervention Patients will be randomized to receive either i biopsy and LITT n10 or ii biopsy alone n10
Study design Prospective randomized pilot study Randomization stopped amendment September 2nd 2021
Study population 20 patients aged 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection
Intervention Patients will be randomized to receive either i biopsy and LITT n10 or ii biopsy alone n10
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None